Melt Pharmaceuticals Doses First Patient in Phase 3 Program of MELT-300 Opioid-Free Sedation

Melt Pharmaceuticals announced that the first patient has been dosed in its phase 3 program evaluating the safety and efficacy of its lead product candidate, MELT-300, a non‑IV, non-opioid tablet that combines fixed doses of midazolam (3mg) and ketamine (50mg). MELT-300 is administered sublingually using Catalent’s proprietary Zydis delivery technology to rapidly dissolve the tablet for absorption across the sublingual mucosa.

The MELT-300 phase 3 clinical trial is a randomized, double-blind, three-arm study comparing – at a 4:1:1 ratio – MELT-300, sublingual midazolam, and sublingual placebo for procedural sedation in 528 patients undergoing cataract surgery at 14 participating clinical sites. The topline readout is expected in the fourth quarter of 2024.

Melt previously announced the results from its MELT-300 phase 2 clinical trial, which compared MELT-300 against (i) sublingual placebo alone, (ii) sublingual midazolam, and (iii) sublingual ketamine in over 300 patients. MELT-300 was statistically superior for procedural sedation compared to all individual comparator arms: (i) sublingual placebo (P<0.0001), (ii) sublingual midazolam (P=0.0129) and (iii) sublingual ketamine (P=0.0096).

“We are very excited to announce the first dosing in our pivotal hase 3 program. Over the past 20 years, a lack of innovation in outpatient procedural sedation has created a significant unmet need, with IV‑administered medications being a procedural mainstay and contributing to an increase in opioid usage," Larry Dillaha, MD, Chief Executive Officer of Melt, said in a company news release. "We believe that MELT-300 could revolutionize procedural sedation while enhancing the patient’s experience in all sites of care by offering greater comfort without a needle stick and by reducing exposure to opioids.”

Dr. Dillaha added, “While we are initially targeting sedation during cataract surgery for MELT-300, estimated to be over 5 million annual procedures in the U.S. in the coming years, we believe with further development and label expansion, MELT-300 could be utilized in over 100 million annual procedures in areas such as dermatology, plastics, dental, gastrointestinal, and emergency rooms.”